FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSIOfiber® Hammertoe Fixation System
DI: 07290017630076
·
Model: OF20025160
·
OSSIO LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OSSIOfiber® Hammertoe Fixation System
- Primary DI
- 07290017630076
- Version / Model
- OF20025160
- Catalog Number
- OF20025160
- Company Name
- OSSIO LTD
- Labeler DUNS
- 600505107
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-12
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- d5cbe4c0-7f11-4734-8991-125f9cb56211
Device Description
The OSSIOfiber® Hammertoe Fixation System, S, 2.5X16 mm, straight 0°. Package contains: 1 K-wire, 1 Drill-Bit, 1 Inserter, 1 Implant straight 0°.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTY | Pin, Fixation, Smooth | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45037 | Orthopaedic bone pin, bioabsorbable | A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017630076 | GS1 |
Customer Contacts
- Phone
- 1-833-781-7373
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190652 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.5 | Millimeter | |
| Length | 16 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose product to temperatures greater than 47°C or 116°F.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at a normal relative humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- 7 – 30 Degrees Celsius